Why it was recalled
Failed Dissolution Specifications
Product description
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Lot numbers, UPCs & expiration codes
a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021
Where it was sold
Product was shipped to wholesalers throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1515-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 19, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- a) 5,472 bottles and b) 5,880 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-1515-2019, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83378
- Address
- 339 Jefferson Rd Ste 101
- Code information
- a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021
- Postal code
- 07054-3707
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1515-2019
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- a) 5,472 bottles and b) 5,880 bottles
- Termination date
- Jun 7, 2021
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
- Distribution pattern
- Product was shipped to wholesalers throughout the United States.
- Recall initiation date
- Jul 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2019